NCT06893588

Brief Summary

A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2025Mar 2027

First Submitted

Initial submission to the registry

February 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

February 3, 2025

Last Update Submit

March 24, 2025

Conditions

Cerebral VasospasmAneurysmal Subarachnoid Hemorrhage (aSAH)

Keywords

vasospasm

Outcome Measures

Primary Outcomes (1)

  • Improvement in target vessel diameter following NeVa VS use

    Up to 1 hour post procedure

Study Arms (1)

Treatment Group

Device: NEVA VS

Interventions

NEVA VSDEVICE

cerebral artery dilation device

Treatment Group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with cerebral vasospasm

You may qualify if:

  • Age ≥22
  • Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
  • Vessel dilation procedure was performed with the NeVa VS
  • Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sharon Shachar, Graduate

CONTACT

2486976616sshachar@vesalio.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

March 25, 2025

Study Start

April 14, 2025

Primary Completion (Estimated)

February 14, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share